The Medical Device Business Journal — Medical Device News & Articles | MassDevice
SeraCare Life Sciences Inc. added healthcare veteran and private equity investor Harold Blue to its managing board.
Blue, a principal at HealthEdge Investment Partners of Tampa, Fla., will join the board of the Milford-based diagnostic services company even as it endures a year-long stock freefall.
On April 3, the Centers for Medicare & Medicaid Services published a decision memorandum announcing significant easing of its coverage requirements for Positron Emission Tomography (PET) testing of solid tumors and myeloma. A minimally invasive diagnostic imaging procedure, PET uses a radioactive tracers to evaluate glucose metabolism in tumors and in normal tissue.
The National Institutes of Health plans to issue $200 million in grants from the American Recovery and Reinvestment Act.
The new grants will serve large-scale research projects with the potential to drive investment and job creation in biomedical research and development, public health and health care delivery.
Scientists and doctors at the Food & Drug Administration wrote a letter April 2 to President Barack Obama to ask that he hold former and current senior officials at the federal watchdog agency accountable for their wrongdoing.
The letter details numerous instances in which FDA officials violated agency rules and, in some cases, federal law. It goes on to say that “sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too long.”
Local medical device firms fared well in Medical Device & Diagnostic Industry magazine’s annual award ceremony.
The awards, now in their 12th year, are sponsored by the magazine and its publisher, Canon Communications, to recognize “achievements of medical device manufacturers, their suppliers, and the many people behind the scenes.” The actual awards will be handed out at Canon’s Medical Design & Manufacturing (MD&M) East conference in June.
Local winners include:
A group of American medical device manufacturers joined to launch a Japanese trade council, the American Medical Devices and Diagnostics Manufacturers’ Assn.
The federal Food & Drug Administration shot down Stryker Corp.‘s application for expanded use of its bone-growth putty after a panel of outside experts voted 6-1 against allowing the expansion, the Reuters news service reported.
The watchdog agency’s panel found that bias may have influenced subjects in clinical trials for the medical device giant’s OP-1 putty, a genetically engineered protein used to stimulate bone growth in spinal surgeries.
Stryker’s biotech division is headquartered in Hopkinton.
Millstone Medical Outsourcing is expanding again, this time at its Memphis operation.
The Fall River-based inspection and clean room services provider is adding 12,000 square feet to its facility in the Bluff City, taking its total to 43,600 square feet and increasing its inspection, storage and distribution capacities.
It’s the second expansion this year for Millstone, which opened a second location in its Fall River home base in February.
Days after closing its difficult deal to acquire Emageon, Amicas Inc. shuttered Emageon’s Birmingham, Ala.-based headquarters and announced plans to lay off about 100 workers there, the Birmingham Terminal reported.
Calls to Amicas seeking comment were not immediately returned.
How do you say, “Pony up” in French?
Whatever the literal translation, that’s what a French court said to medical device monoliths Boston Scientific Corp. and Medtronic Inc. after the pair lost a bid to squelch an anti-trust case there, the Bloomberg news service reported via Boston.com.
United State military personnel will see their medical records go digital as part of President Barack Obama’s more than $3 trillion 2010 budget, the Wall Street Journal reported.
The joint project between the Defense Dept. and the Dept. of Veterans Affairs will involve the creation of an electronic database of administrative and medical information for U.S. service members for what Obama called a “seamless system” that will cut red tape and end the need for veterans to transfer military records for their benefits.
The so-called “Joint Virtual Lifetime Record” is expected to begin upon enlistment and track personnel throughout their military careers and beyond.
